Israel-headquartered XTL Biopharmaceuticals, which is also listed on the Nasdaq, has seen its shares in the USA tumble 95% after a mid-stage trial of bicifadine, a treatment for diabetic neuropathic pain, failed to meet its primary goal.
The company released top-line results from its bicifadine Phase IIb clinical trial for the treatment of DNP. The trial’s primary objective was to compare the efficacy of two doses of bicifadine against placebo but the XTL drug did not reduce pain significantly more than the placebo.
The study also failed to meet key secondary analysis, XTL said. Chief executive Ron Bentsur said that “we will devote the next few days to further analyse the data and decide on the appropriate course of action for the bicifadine program, and for the company”.
Investors seem to have made their minds up, however, as bicifadine is the only drug XTL has in clinical development. It currently has around $6 million in cash.
DNP represents an area of unmet medical need and only two drugs have been approved for the condition – Pfizer’s Lyrica (pregabalin) and Eli Lilly’s Cymbalta (duloxetine).
